NCT00591123

Study of Erlotinib and Chemotherapy for Unresectable or Metastatic Cancer of the Esophagus and Gastric Cardia

A Phase II Study of Erlotinib and Modified FOLFOX-6 (5-Fluorouracil, Leucovorin and Oxaliplatin) in Previously Untreated Patients With Unresectable or Metastatic Adenocarcinoma of the Esophagus and Gastric Cardia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Translational Oncology Research International · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study, Erlotinib and 5-Fluorouracil (5-FU), Leucovorin and Oxaliplatin (a regimen known also as FOLFOX-6) will be the chemotherapy study drugs. The main purpose of this study is to test the safety and effectiveness of this combination of chemotherapy drugs and to see how they affect your cancer. Another purpose of this study is to examine samples from your blood and tumor. This research will be done to better understand how subjects respond to treatment. Specifically, researchers will look at the way your genes and proteins respond to drugs like those used in this study.

Conditions

• Unresectable Adenocarcinoma of the Esophagus
• Metastatic Adenocarcinoma of the Esophagus
• Unresectable Adenocarcinoma of Gastric Cardia
• Metastatic Adenocarcinoma of Gastric Cardia

Interventions

Type	Name	Description
DRUG	FOLFOX	Once every two weeks all patients will receive Oxaliplatin 85 mg/m2 IV, Leucovorin 400 mg/m2 IV and 5-FU 400 mg/m2 IV infusions
DRUG	5-FU	5-FU 2400 mg/m2 IV will be given via pump for 46-48 hours at home.
DRUG	Erlotinib	All patients will also be given Erlotinib, 100 mg orally daily for the first 4 weeks. Those patients who have not experienced toxicities will increase the dose level to 150 mg daily. Patients who have toxicities will remain at the 100 mg dose level or lower if necessary.

Timeline

• Start date: 2007-12-01
• Primary completion: 2011-06-01
• Completion: 2015-09-01
• First posted: 2008-01-11
• Last updated: 2021-10-01
• Results posted: 2021-10-01

Locations

2 sites across 1 country: United States